PRAX

Product NDC: 0496-0748
11-digit product format: 004960748
Labeler code: 0496
Product ID: 0496-0748_297a2f2f-8355-6e34-e063-6394a90add60
Type: HUMAN OTC DRUG
Nonproprietary name: pramoxine hydrochloride
Dosage form: LOTION
Route: TOPICAL
Labeler: Ferndale Laboratories, Inc.
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-04-01
Substance: PRAMOXINE HYDROCHLORIDE
Active strength: 10 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: PRAX
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PRAMOXINE HYDROCHLORIDE	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
88AYB867L5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1246075	Internal RxNorm lookup
1246076	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
674f0d8b-3d50-42b1-8401-d2967bcdf5cf	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0496-0748-03	PRAX	237 mL in 1 BOTTLE	LOTION	237	3
0496-0748-04	PRAX	118 mL in 1 BOTTLE	LOTION	118	3
0496-0748-15	PRAX	15 mL in 1 BOTTLE	LOTION	15	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0496-0748-03	ML - Milliliter	0496-0748	b6504dad-0912-4d55-9453-e5d6c6a530c0	1	2013-07-02
0496-0748-04	ML - Milliliter	0496-0748	b54a913e-a7ae-4fa8-ac21-94664fed7c1b	1	2013-07-02
0496-0748-15	ML - Milliliter	0496-0748	04165e3a-56fa-4666-879e-9ba452700668	1	2013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PRAMOXINE HYDROCHLORIDE	ACTIVE INGREDIENT	88AYB867L5	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
PRAMOXINE	ACTIVE MOIETY	068X84E056	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
DIISOPROPYL ADIPATE	INACTIVE INGREDIENT	P7E6YFV72X	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
HYDROGENATED COCONUT OIL	INACTIVE INGREDIENT	JY81OXM1OM	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
SORBITAN SESQUIOLEATE	INACTIVE INGREDIENT	0W8RRI5W5A	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0496-0748	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	3	Current NDC, Legacy NDC, 3 package rows	20241219_674f0d8b-3d50-42b1-8401-d2967bcdf5cf.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 22 · 434 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gembooxt Topical Numbing Cream	LIDOCAINE	Guangdong Quadrant Ecological Technology Co., Ltd.	49951a3e-3b62-3d66-e063-6294a90a9360	2026-08-12	Warnings	Exact identifier application number: M015
NumbMD Lidocaine Cream Anorectal(hemorrhoidal)	LIDOCAINE 5%	EveryMarket Inc	52379055-d017-4d98-e063-6294a90a196c	2026-08-12	Warnings	Exact identifier application number: M015
Nupharmisto NumbMD Lidocaine Cream	LIDOCAINE 5%	EveryMarket Inc	52369a41-820d-cd7a-e063-6394a90ac6d1	2026-08-12	Warnings	Exact identifier application number: M015
Nupharmisto NumbMD Lidocaine Cream	LIDOCAINE 5%	EveryMarket Inc	51d370b4-1c34-d203-e063-6394a90a80b1	2026-08-12	Warnings	Exact identifier application number: M015
Nupharmisto NumbMD 5% Lidocaine cream	LIDOCAINE 5%	EveryMarket Inc	507d0c2c-9517-40f8-e063-6394a90a1996	2026-08-12	Warnings	Exact identifier application number: M015
Nupharmisto NumbMD LIDOCAINE cream anorectal (hemorrhoidal)	LIDOCAINE CREAM ANORECTAL	EveryMarket Inc	483d81a3-7493-3391-e063-6394a90a2e3d	2026-08-12	Warnings	Exact identifier application number: M015
Numbing Cream	LIDOCAINE	100 KARMA INC	35b5ba9d-da1d-55d6-e063-6294a90a5fa8	2026-08-12	Warnings	Exact identifier application number: M015
Treatonic hemorrhoid treatment	5% LIDOCAINE	100 KARMA INC	41442fa7-c511-07ca-e063-6294a90a3992	2026-08-12	Warnings	Exact identifier application number: M015
Lidocaine numbing cream	5% LIDOCAINE	100 KARMA INC	47380721-6633-4a50-e063-6394a90aca94	2026-08-12	Warnings	Exact identifier application number: M015
Treatonic 5% Lidocaine Cream	5% LIDOCAINE CREAM	100 KARMA INC	47dc7630-9a74-1989-e063-6294a90a50bb	2026-08-12	Warnings	Exact identifier application number: M015
Treatonic 5% Lidocaine Cream	5% LIDOCAINE CREAM	100 KARMA INC	49e6b69f-bd6e-b415-e063-6394a90a8e65	2026-08-12	Warnings	Exact identifier application number: M015
THE SOLU TION	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE HYDROCHLORIDE	SCALP TECH INC	58793581-8826-9a74-e063-6294a90a2465	2026-08-06	Warnings	Exact identifier application number: M015
Lidocaine Numbing Cream	LIDOCAINE	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	5457b3d7-e6b6-34a7-e063-6394a90aa240	2026-08-03	Warnings	Exact identifier application number: M015
HEMORRHOIDALCREAMPROCURE	PHENYLEPHRINE HCL, PETROLATUM, MINERAL OIL	TWIN MED, LLC	e9c44756-1c98-41be-e053-2995a90a35b4	2026-08-03	Warnings	Exact identifier application number: M015
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	YYBA CORP	582a0001-da1e-909a-e063-6394a90a2b11	2026-08-03	Warnings	Exact identifier application number: M015
up and up	PHENYLEPHRINE HYDROCHLORIDE	Target Corporation	b42775ae-44fe-487e-b9ca-21d9687020a9	2026-07-29	Warnings	Exact identifier application number: M015
Acolye Numbing Cream Anorectal(Hemorrhoidal) Cream	LIDOCAINE	Guangdong Aimu Biological Technology Co., Ltd	578fa642-ff30-e511-e063-6294a90a5987	2026-07-26	Warnings	Exact identifier application number: M015
CVS Topical Anesthetic Hemorrhoidal	DIBUCAINE	CVS PHARMACY, INC	9f3d4fdb-ad82-4ab8-8a9e-252d027068ab	2026-07-25	Warnings	Exact identifier application number: M015
Moisture Barrier	MENTHOL 0.44%, ZINC OXIDE 20.6%	Walgreen Company	258f3392-0f42-21e8-e063-6294a90ae9ad	2026-07-22	Warnings	Exact identifier application number: M015
RectaEase Hemorrhoid Relief Cream	LIDOCAINE	Trifecta Pharmaceuticals USA LLC	c054921a-9f1b-7c75-e053-2995a90a1738	2026-07-20	Warnings	Exact identifier application number: M015

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1246075	pramoxine HCl 1 % Topical Lotion	PSN	674f0d8b-3d50-42b1-8401-d2967bcdf5cf	3
1246076	Prax 1 % Topical Lotion	PSN	674f0d8b-3d50-42b1-8401-d2967bcdf5cf	3
1246076	pramoxine hydrochloride 10 MG/ML Topical Lotion [Prax]	SBD	674f0d8b-3d50-42b1-8401-d2967bcdf5cf	3
1246075	pramoxine hydrochloride 10 MG/ML Topical Lotion	SCD	674f0d8b-3d50-42b1-8401-d2967bcdf5cf	3
1246075	pramoxine hydrochloride 1 % Topical Lotion	SY	674f0d8b-3d50-42b1-8401-d2967bcdf5cf	3
1246076	Prax 1 % Topical Lotion	SY	674f0d8b-3d50-42b1-8401-d2967bcdf5cf	3
1246076	Prax 10 MG/ML Topical Lotion	SY	674f0d8b-3d50-42b1-8401-d2967bcdf5cf	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0496-0748-03	00496074803	237 mL in 1 BOTTLE (0496-0748-03)	237 ml	2012-04-01	0000-00-00	No	No	Current
0496-0748-04	00496074804	118 mL in 1 BOTTLE (0496-0748-04)	118 ml	2012-04-01	0000-00-00	No	No	Current
0496-0748-15	00496074815	15 mL in 1 BOTTLE (0496-0748-15)	15 ml	2012-04-01	0000-00-00	No	No	Current